CLINICAL STUDY
A Single-Incision Technique for Placement of Implantable Venous Access Ports via the Axillary Vein Tae-Seok Seo, MD, PhD, Myung Gyu Song, MD, Eun-Young Kang, MD, PhD, Chang Hee Lee, MD, PhD, Hwan Seok Yong, MD, PhD, and KyungWon Doo, MD, PhD
ABSTRACT Purpose: To evaluate the technical feasibility and safety of a single-incision technique for placement of implantable venous access ports via the axillary vein. Materials and Methods: Ports were placed in 216 patients between May and October 2012 using a single-incision technique via the axillary vein. Patients included 112 men and 104 women with a mean age of 58.2 years. After making a single vertical incision without subcutaneous tunneling, ports were placed via the left axillary vein in 172 patients and via the right axillary vein in 44 patients. Axillary vein punctures were directed medially at the incision site under ultrasound guidance. We retrospectively reviewed success rates, technical difficulties, procedure times, and immediate and delayed complications of the procedure. Results: All single-incision port placements were technically successful. Technical difficulties occurring during the procedure included advancement of the wire or catheter into an unintended vein (n ¼ 33), kinking at the cuff-catheter junction (n ¼ 13), bleeding via the puncture tract (n ¼ 5), bending of the peel-away sheath (n ¼ 3), and puncture of the axillary artery (n ¼ 3). All technical problems were overcome with additional manipulation. The only immediate complication was puncture site hematoma in two patients. The mean follow-up period was 165.7 days, and there were no reports of port malfunction. Axillary vein thrombosis was observed in one patient. Conclusions: The single-incision technique for placing ports via the axillary vein was a feasible and safe procedure with high technical success and low risk of complications.
ABBREVIATIONS IJV = internal jugular vein, SCV = subclavian vein, SVC = superior vena cava
Since first reported by Niederhuber et al (1), implantable venous access ports have been widely used, and many studies have demonstrated their safety and reliability (2– 4). The first port implantation was performed using a surgical approach via the cephalic vein. Radiologically guided implantation has been increasing in popularity since Morris et al (5) described a percutaneous technique
From the Department of Radiology, Korea University College of Medicine, Korea University Guro Hospital, #148, Gurodong-ro, Guro-gu, Seoul 152-703, Korea. Received September 3, 2013; final revision received and accepted December 27, 2013. Address correspondence to: T.-S.S.; E-mail: [email protected] None of the authors have identified a conflict of interest. & SIR, 2014 J Vasc Interv Radiol 2014; XX:]]]–]]] http://dx.doi.org/10.1016/j.jvir.2013.12.571
in which puncture of the internal jugular vein (IJV) or subclavian vein (SCV) was performed in the interventional suite (1,6,7). Although these techniques used many different veins, the IJV is the ideal vessel for placement of tunneled catheters (7–10). The most popular technique for placing ports under radiologic guidance is creation of a tunnel between the venipuncture site and port pocket in the infraclavicular area after IJV puncture. Use of conventional IJV interventional radiologic techniques during port placement and follow-up presents several potential disadvantages. Immediate problems that may occur during the procedure include pain at the tunneling site secondary to tissue traction, ecchymosis of the skin overlying the subcutaneous tunnel especially in older patients, and incorrect measurement of catheter length. Problems that may arise during the follow-up period include discomfort with neck
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movement or swallowing and cosmetic issues caused by palpation of the catheter over the clavicle in patients with little subcutaneous fat. A single-incision technique was designed for placing ports by puncturing the axillary vein without the subcutaneous tunneling used in conventional techniques. In this article, we describe this new technique and evaluate the feasibility, technical success, and complications of the procedure.
MATERIALS AND METHODS The institutional review board of our institution approved this retrospective study, and the requirement for written informed consent was waived. Between May and October 2012, ports were placed in 216 of 241 patients using a single-incision technique via the axillary vein in an interventional radiology suite. Patients included 112 men and 104 women with a mean age of 58.2 years (range, 17–84 y). All patients had malignancies, as shown in Table 1, and a treatment plan including chemotherapy using ports. Ports were placed in 25 patients with high body mass index or pendulous breasts using a conventional technique via the IJV. Before the procedure, written informed consent including advantages and expected complications was obtained from all patients. All ports were placed by one interventional radiologist. If not contraindicated, the left axillary vein was preferred because its course to the superior vena cava (SVC) is more obtuse. Access routes were selected by ultrasound (US) examination of the axillary vein before the procedure. Ports were placed via Table 1 . Underlying Malignancies Malignancies
N (216 Patients)
Breast cancer (left 25, right 31) Stomach cancer
56 29
Colon cancer
28
Lung cancer Rectal cancer
23 12
Lymphoma
11
Esophageal cancer Cholangiocellular carcinoma
7 5
Ovarian cancer
5
Pancreatic cancer Other malignancies
5 35
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the left axillary vein in 172 patients and via the right axillary vein in 44 patients. The most common reason for accessing the right axillary vein was port placement in the contralateral chest for patients with left-sided breast cancer (n ¼ 25) (Table 2). The ports placed included the 6.5-F Celsite Discreet STR or STL type (B. Braun Medical, Boulogne Cedex, France), 6.5-F Celsite ST type (B. Braun Medical), and 8-F Healthport (Baxter Healthcare SA, Zurich, Switzerland) (Table 3). Before disinfecting the skin and sterile draping, the direction of the axillary vein was identified using US guidance, and an incision line was drawn on the skin (Fig 1). The incision line was typically 3 cm lateral to the junction of the axillary vein and clavicle to reduce the risk of pinch-off syndrome and disturbance of shoulder motion. Local anesthesia was injected into the incision line, puncture tract, and port pocket, and a 2-cm vertical incision was made. The axillary vein was punctured under US guidance using a micropuncture needle from a Micronitinol rapid access kit (Access Point Technologies, Rogers, Minnesota). Puncture was initiated at the cephalic end of the incision line for the medial pocket and the midportion for the lateral pocket (Fig 2). A 0.018-inch microwire was advanced, and a microintroducer was inserted. Vein puncture was confirmed by visualization of the microwire in the right atrium on fluoroscopic imaging (Fig 3). Port pockets were created medial or lateral to the incision line by blunt dissection of the subcutaneous tissue. Early on in using this technique, the pocket was created lateral to the incision line for placement of a Celsite ST type or Healthport, and later the pocket was placed medially when the Celsite Discreet port became available. The catheter was introduced through a peel-away sheath.
Table 2 . Reasons for Access via the Right Axillary Vein Reasons
N (44 Patients)
Left-sided breast cancer
25
Lymph node enlargement around left axillary vein
7
Mass in left side of the neck
5
Problems with left axillary vein Dilated vascular structures in
4 2
infraclavicular area Left shoulder pain
1
Table 3 . Types of Ports and Pockets
Medial pocket (n ¼ 123) Lateral pocket (n ¼ 93) Total
Celsite Discreet STR Celsite Discreet STL
Left Axillary Vein
Right Axillary Vein
Total
88 0
0 35
88 35
Celsite ST
42
2
44
Healthport
42 172
7 44
49 216
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After placing the catheter tip in the middle portion of the right atrium and connecting it to the port chamber, the port was implanted in the pocket. A final fluoroscopic image confirmed the position of the catheter tip and port chamber. In all cases, additional plain chest radiographs were obtained to identify immediate complications and to confirm the position of the catheter tip and port chamber (Fig 4a, b). Sutures were removed 7–10 days after the procedure.
Figure 1. Marker for axillary vein direction and the incision line. Two cephalic markers (short arrows) indicate axillary vein direction and two caudal makers (long arrows) indicate the incision line.
Figure 2. Puncture of the axillary vein. For medial pockets, puncture was performed under US guidance at the cephalic end of the incision line. The upper two markers (arrows) indicate the direction of the axillary vein.
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Procedure details were retrospectively reviewed, including technical success rates, location of the micropuncture needle tip on fluoroscopic imaging obtained after puncture, procedure time, fluoroscopy time, extrinsic catheter compression on fluoroscopic imaging, and plain chest radiography performed after the procedure. Complications were identified according to criteria set forth by the Society of Interventional Radiology (SIR) (11). Immediate complications, problems encountered during implantation, and manipulations used to troubleshoot these issues were also retrospectively reviewed. Procedure time was defined as the time from initial imaging after puncture to final imaging after the suture on a picture archiving and communication system. The location of the needle tip was classified according to the following six categories relative to the rib margin: medial, overlapping, or lateral to the first or second rib (Fig 3). If the needle tip was located in the first intercostal space, the location was considered to be near-sided. Medical records and chest computed tomography (CT) scans were retrospectively reviewed to evaluate patient progress, port function, delayed complications, and treatment. The length of follow-up was calculated from port placement to removal or the last follow-up day. Ports were removed in 34 patients. In 123 patients who still had the devices in place, the duration from placement to the cutoff day of March 1, 2013, was calculated. For patients who died (n ¼ 32), were lost to follow-up (n ¼ 17), or were transferred to other hospitals (n ¼ 10) before the cutoff day, the last visit recorded in the medical record was used. Contrast-enhanced chest CT scans were obtained for 192 patients to evaluate
Figure 3. Fluoroscopic image obtained after puncture. The tip of the micropuncture needle (arrow) is located lateral to the lateral margin of the first rib, and the microwire tip is in the right atrium.
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changes in underlying disease and metastasis. Contrast medium (Visipaque 270; GE Healthcare Ireland, Cork, Ireland) was injected into veins of the ipsilateral or contralateral upper extremity or port. On average, 2.5 (range, 1–6) follow-up chest CT scans were performed. The mean duration between port placement and the last day of CT imaging was 133.1 days (range, 0–293 d). On coronal reformatted images, the entry point into the vein was evaluated using the same classification as previously described for the location of the needle tip on fluoroscopic imaging. In addition, catheter-related thrombosis and vein stenosis were evaluated from the brachial vein to the SVC including interruption of flow, filling defects caused by thrombi, and thrombophlebitis. Statistical differences in procedure and fluoroscopy times were analyzed using Student t-tests (SPSS 20.0; SPSS, Inc, Chicago, Illinois).
RESULTS All procedures using the single-incision technique for port placement were successful. Mean fluoroscopy time was 0.65 minutes (range, 0.2–3.5 min), and mean procedure time was 13 minutes, 39 seconds (range, 10
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min, 37 s to 32 min, 22 s) (Table 4). Mean procedure times for medial and lateral pockets were 13 minutes, 16 seconds, and 14 minutes, 10 seconds. Analysis using Student t-tests indicated a statistically significant difference (P ¼ .034). Differences in mean procedure time for right-sided or left-sided access and mean fluoroscopy times according to the method used were not statistically significant. The most common needle tip location was overlapping with the first rib on fluoroscopic imaging, which occurred in 111 cases (51.4%) (Table 5). There were 114 (52.8%) needle tips medial to the lateral margin of the first rib. The entry points into the vein on CT scan were the axillary vein and SCV in 161 and 31 of 192 patients, respectively (Table 5). In 31 cases of SCV puncture, the position of the entry point relative to the clavicle was lateral (n ¼ 22), marginal (n ¼ 6), and overlapping (n ¼ 3). No extrinsic catheter compression or pneumothorax was detected on fluoroscopic or plain chest images obtained after the procedure. Complications were reported in three patients (1.4%), including one major and two minor complications. The major complication was thrombosis of the axillary vein during the follow-up period, and the two minor complications were hematoma formation after accidental punc-
Figure 4. Posteroanterior views on plain chest radiography in the upright position. (a) Celsite Discreet port (STR type) is noted medial to the incision (line) in a male patient. (b) Healthport is noted lateral to the incision (line) in a female patient. The port is located near the shoulder joint and shows caudad migration.
Table 4 . Mean Fluoroscopy and Procedure Times Procedure Time (min:s) Total Access route
Pocket location
n
Statistically significant.
Fluoroscopy Time (min)
13:39 (range, 10:37–32:22)
0.65 (range, 0.2–3.5)
Left (n ¼ 172)
13:48
0.61
Right (n ¼ 44) P value
13:06 .098
0.81 .116
Medial (n ¼ 123)
13:16
0.65
Lateral (n ¼ 93) P value
14:10 .034*
0.64 .832
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Table 5 . Locations of the Needle Tip on Fluoroscopic and CT Imaging 1st Rib
1st Rib
1st Rib
2nd Rib
2nd Rib
2nd Rib
Medial
Overlapping
Lateral
Medial
Overlapping
Lateral
3
28 63
29
2nd rib medial
9
16
12
6
2nd rib overlapping 2nd rib lateral
1
3
11
10
Fluoro/CT 1st rib medial
Total 0
1st rib overlapping 1st rib lateral
No follow-up CT Total
3
31 92
10
3
3
8
111
51
26
24
43 1
26 0
1
216
24
CT ¼ computed tomography; Fluoro ¼ fluoroscopy.
Table 6 . Problems Encountered during the Procedure Problems
N
Advancement of device into unintended vein Catheter tip
33 14
Microwire Spring wire Catheter kinking
11 8 13
Tract bleeding
5
Sheath bending Axillary artery puncture
3 3
Preexisting stenosis of brachiocephalic vein
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ture of the axillary artery. Problems that occurred during the procedure are listed in Table 6. The most common problem was advancement of the wire or catheter into unintended veins, which occurred in 33 patients, although these were easily redirected with minor manipulation under fluoroscopic guidance. This problem occurred in 7 of 44 patients (15.9%) with access via the right axillary vein and 26 of 172 patients (15.1%) with access via the left axillary vein. The catheter tip was wedged into the azygos vein in five cases, and three catheters were advanced into the SVC and right atrium with a “U” shape by pushing from outside of the body. Kinking of the catheter at the junction between the cuff and the catheter occurred in 13 patients, 10 of whom had port pockets that were medial to the incision (8.1%) and 3 of whom had port pockets that were lateral (3.2%) (Fig 5a, b). This kinking was corrected by dissection of the tissue between the puncture tract and port pocket. Bleeding via the puncture tract was observed in five patients, all of whom had lateral pockets. Bleeding resolved completely with placement of a purse-string suture around the port cuff in the subcutaneous tissue. Bending of the peel-away sheath occurred in three patients, all of which were accessed via the right axillary vein. Bending of the peelaway sheath disturbed catheter passage, which was overcome by pulling the sheath while pushing the catheter. The axillary artery was initially punctured in
Figure 5. Catheter kinking at the junction between the cuff and the catheter in cases with a medial (a) and lateral pocket (b).
three patients. The needle was immediately removed, and manual compression was applied to the site. In two patients, axillary vein punctures were remedied by a second puncture under ultrasound guidance. In one patient, the axillary vein had collapsed secondary to hematoma formation, and repuncture was possible only under venography guidance. No cases involved converting
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Figure 6. A 60-year-old man with left axillary vein thrombosis 196 days after port placement. (a) Upper extremity CT venogram obtained before removing the port shows no contrast media filling in the left axillary vein (white arrows) compared with the right axillary vein (black arrows). Infiltration from associated central vein thrombophlebitis is noted in the left axilla. (b) Follow-up CT image obtained after port removal and 3 months of anticoagulation shows restoration of blood flow in the left axillary vein (arrows) and improved thrombophlebitis in the left axilla.
a conventional technique to access via the IJV or contralateral axillary vein. The mean follow-up period was 165.7 days (range, 9– 303 d), and all ports functioned well throughout this time interval. No incision or port pocket infections were reported. The only delayed complication was thrombosis of the axillary vein. One patient complained of left upper extremity edema 196 days after port placement via the left axillary vein. Upper extremity CT venograms obtained the next day showed thrombosis of the left axillary vein with thrombophlebitis of the deep veins in the left upper extremity (Fig 6a). The port was removed, and symptoms improved with anticoagulation therapy over the course of 3 months. Follow-up CT venograms showed resolution of the thrombus (Fig 6b). No case of pinch-off syndrome was identified. Except for the abovedescribed patient, none of the remaining 191 patients showed any evidence of stenosis or thrombosis of the central vein or pulmonary embolism on follow-up CT scans. Ports were removed in 34 patients because of completion of chemotherapy (n ¼ 31), bloodstream infection (n ¼ 2), or axillary vein thrombosis (n ¼ 1). The duration from port placement to removal because of bloodstream infection was 93 days and 256 days.
DISCUSSION Conventional techniques for placing tunneled catheters or ports use two incisions to create a subcutaneous tunnel between the skin exit site or port pocket incision and the venipuncture site. This technique has potential drawbacks, including the use of two separate incisions, cosmetic issues that accompany a neck incision to gain access to the IJV, difficulty advancing tunneling devices, incorrect measurement of catheter length, catheter malfunction, and venous thrombosis (12,13). Creation of subcutaneous tunnels in the deep tissue was not possible because of small amounts of subcutaneous fat, especially
in patients who had undergone gastrectomy for gastric cancer and women with low body mass index. Some patients expressed dissatisfaction with being able to palpate the catheter over the clavicle. Despite use of local anesthesia, tunneling was painful in some patients. Ecchymosis in the overlying skin could occur with gentle advancement of the device through the subcutaneous tissue. To overcome these disadvantages associated with the conventional technique for placing tunneled catheters, a single-incision technique to access the IJV was used via an incision in the infraclavicular area (12–14). Potential advantages of the single-incision technique include cosmetic benefits because of elimination of neck incisions, reduction of discomfort after the procedure, and easier placement in patients with a tracheostomy. However, this technique also has some drawbacks, such as limited subcutaneous tunnel length based on needle length, a potentially inaccessible IJV depending on patient anatomy or available needle length, and difficulty advancing devices with a hairpin-turn shape. The mean procedure time for implanting ports using the previously reported single-incision technique was 25 minutes (range, 18–36 min) from injection of local anesthesia to suture placement. The mean procedure time in the current study was much shorter than that of previous reports, although an exact comparison could not be made. In previous reports, procedure times were much longer when accessing the left IJV. In the current study, the level of difficulty was the same for right-sided and left-sided approaches, and procedure times were similar regardless of the access route. There continues to be controversy regarding which access route and technique are ideal because each carry potential complications. Surgeons have traditionally preferred to access the subclavian vein, cephalic vein, and IJV via cutdown or Seldinger technique under US guidance (3,15–17). The SCV is a suitable anatomic landmark for puncture but can develop symptomatic
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thrombosis and stenosis (16,18). Central venous access via the percutaneous technique has been increasing in popularity more recently. The right IJV is the best route for US-guided access in interventional radiology because of its large diameter, superficial location, straight course to the right atrium, high success rate, and low complication rate (7,9,19,20). Incidence of catheter-related thrombosis is lower when using an IJV versus a SCV approach (8,9,21). Trerotola et al (9) reported 3.2% and 12.6% overall complication rates after central venous access via the IJV and SCV, respectively. The incidence of thrombosis per 100 catheter days was 0.04 and 0.12 in patients with a catheter via the IJV and SCV, respectively. Symptomatic thrombosis is more frequent after access via the SCV, causing acute arm swelling (17). Another risk of access via the SCV includes development of pinch-off syndrome (22). In this study, the axillary vein was punctured instead of the SCV. Axillary vein puncture under US guidance is easier than SCV puncture and reduces the risk of pinchoff syndrome, although it may be more difficult to puncture than IJV. In some cases, the axillary artery was punctured by missing the needle tip during tracing. Micropuncture needle tips were located medial to the lateral margin of the first rib in 114 patients, which is the border between the SCV and the axillary vein. Extrinsic catheter compression was not noted in all patients, and pinch-off syndrome did not develop during the follow-up period in 102 patients. This was likely because the true entry sites were lateral to the lateral margin of the first rib (83.9%) and were located between the clavicle and the first rib in only 3 (1.6%) of 192 cases on follow-up chest CT scan. Only one patient developed symptomatic thrombosis at 196 days after placement, and this incidence was very low (0.5%) compared with previous reports (8,9,21). There was no evidence of thrombosis, stenosis, or pulmonary embolism on follow-up CT scan in 191 patients. However, thrombosis may be underestimated in cases in which the contrast medium was administered via veins in the contralateral upper extremity or port. Factors that influence catheter-related thrombosis are clinician experience, type of catheter, catheter insertion side, catheter tip malposition, indication for catheter placement, and underlying patientrelated risk factors such as a hypercoagulable state (15). Possible reasons for the low incidence of thrombosis in this study are small diameter of the port catheters and use of a less traumatic method for accessing vessels by using a micropuncture needle. Left-sided access was preferred for the single-incision technique because the course to the SVC is more acute on the right side. Another advantage of left-sided access was minimal disturbance of shoulder motion, although the port was implanted near the joint because most people were right-handed, and a medial port pocket incision was preferred to a more lateral one. The mean procedure time was shorter with medial compared with lateral pockets,
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and overall the procedure was simpler. The use of one incision for the port pocket and puncture tract carries a potential risk for bacterial migration into the bloodstream owing to the lack of a subcutaneous tunnel, even though the puncture tract was usually 4 3 cm from incision to entry site (23). Whether the puncture tract formed using the single-incision technique is long enough to provide a barrier against bacterial migration is unknown, but there were no cases of pocket infection in this study. In terms of problems encountered during the procedure, catheter kinking developed mainly during the early period after use of the Celsite Discreet type, and this was corrected by dissection of the tissue between the puncture tract and port pocket. Catheter kinking did not routinely occur after dissection of the tissue. The mechanism by which kinking occurs is likely similar to that seen with the traditional technique, in which there is bending of the catheter between the tunnel and puncture tract. Bending of the peel-away sheath also developed in at least three cases in which the right side was accessed. Early on, the shape of the peel-away sheath was inspected using fluoroscopy if resistance was detected while advancing the catheter through the sheath. After experience with three cases, the peel-away sheath was removed while simultaneously pushing the catheter without fluoroscopic examination. This study has several limitations. First, because this was a retrospective review, some data were unavailable, and port pocket location was not randomized. In addition, patient follow-up and CT imaging were inconsistent. Problems that developed during the follow-up period were likely underestimated because of the number of patients who died, were lost to follow-up, or transferred to other hospitals. Second, patient selection was not consecutive. Patients with high body mass index or pendulous breasts had ports that were placed via the right IJV using the conventional technique. These patients were excluded because migration distances were long, and catheter tips were often located in the SVC despite initial placement in the right atrium. These patients had a high risk of thrombosis because it is anatomically difficult to return the catheter tip to the SVC or right atrium spontaneously in cases of migration into the left brachiocephalic vein. Another reason for exclusion of these patients was difficulty in puncturing the axillary vein because of its deep location. Third, the follow-up period was short, and the longest follow-up time was 300 days. It is possible that the incidence of delayed complications, such as catheter-related venous thrombosis or pinch-off syndrome, may have increased with a longer follow-up period. Fourth, patient satisfaction was not surveyed. However, patients who visited the outpatient interventional radiology department for suture removal after implantation or explantation expressed satisfaction. The most commonly cited reasons were cosmetic advantages over port placement using the conventional technique.
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In conclusion, the single-incision technique for port placement via the axillary vein was a feasible and safe procedure with high technical success and a low risk of complications. This technique may be an alternative approach to traditional port placement. A prospective randomized study comparing this technique with the conventional technique and including long-term followup and surveillance of patient satisfaction is needed.
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A Single-Incision Technique for Placement of Implantable Venous Access Ports via the Axillary Vein Tae-Seok Seo, MD, PhD, Myung Gyu Song, MD, Eun-Young Kang, MD, PhD, Chang Hee Lee, MD, PhD, Hwan Seok Yong, MD, PhD, and KyungWon Doo, MD, PhD
ABSTRACT Purpose: To evaluate the technical feasibility and safety of a single-incision technique for placement of implantable venous access ports via the axillary vein. Materials and Methods: Ports were placed in 216 patients between May and October 2012 using a single-incision technique via the axillary vein. Patients included 112 men and 104 women with a mean age of 58.2 years. After making a single vertical incision without subcutaneous tunneling, ports were placed via the left axillary vein in 172 patients and via the right axillary vein in 44 patients. Axillary vein punctures were directed medially at the incision site under ultrasound guidance. We retrospectively reviewed success rates, technical difficulties, procedure times, and immediate and delayed complications of the procedure. Results: All single-incision port placements were technically successful. Technical difficulties occurring during the procedure included advancement of the wire or catheter into an unintended vein (n ¼ 33), kinking at the cuff-catheter junction (n ¼ 13), bleeding via the puncture tract (n ¼ 5), bending of the peel-away sheath (n ¼ 3), and puncture of the axillary artery (n ¼ 3). All technical problems were overcome with additional manipulation. The only immediate complication was puncture site hematoma in two patients. The mean follow-up period was 165.7 days, and there were no reports of port malfunction. Axillary vein thrombosis was observed in one patient. Conclusions: The single-incision technique for placing ports via the axillary vein was a feasible and safe procedure with high technical success and low risk of complications.
ABBREVIATIONS IJV = internal jugular vein, SCV = subclavian vein, SVC = superior vena cava
Since first reported by Niederhuber et al (1), implantable venous access ports have been widely used, and many studies have demonstrated their safety and reliability (2– 4). The first port implantation was performed using a surgical approach via the cephalic vein. Radiologically guided implantation has been increasing in popularity since Morris et al (5) described a percutaneous technique
From the Department of Radiology, Korea University College of Medicine, Korea University Guro Hospital, #148, Gurodong-ro, Guro-gu, Seoul 152-703, Korea. Received September 3, 2013; final revision received and accepted December 27, 2013. Address correspondence to: T.-S.S.; E-mail: [email protected] None of the authors have identified a conflict of interest. & SIR, 2014 J Vasc Interv Radiol 2014; XX:]]]–]]] http://dx.doi.org/10.1016/j.jvir.2013.12.571
in which puncture of the internal jugular vein (IJV) or subclavian vein (SCV) was performed in the interventional suite (1,6,7). Although these techniques used many different veins, the IJV is the ideal vessel for placement of tunneled catheters (7–10). The most popular technique for placing ports under radiologic guidance is creation of a tunnel between the venipuncture site and port pocket in the infraclavicular area after IJV puncture. Use of conventional IJV interventional radiologic techniques during port placement and follow-up presents several potential disadvantages. Immediate problems that may occur during the procedure include pain at the tunneling site secondary to tissue traction, ecchymosis of the skin overlying the subcutaneous tunnel especially in older patients, and incorrect measurement of catheter length. Problems that may arise during the follow-up period include discomfort with neck
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movement or swallowing and cosmetic issues caused by palpation of the catheter over the clavicle in patients with little subcutaneous fat. A single-incision technique was designed for placing ports by puncturing the axillary vein without the subcutaneous tunneling used in conventional techniques. In this article, we describe this new technique and evaluate the feasibility, technical success, and complications of the procedure.
MATERIALS AND METHODS The institutional review board of our institution approved this retrospective study, and the requirement for written informed consent was waived. Between May and October 2012, ports were placed in 216 of 241 patients using a single-incision technique via the axillary vein in an interventional radiology suite. Patients included 112 men and 104 women with a mean age of 58.2 years (range, 17–84 y). All patients had malignancies, as shown in Table 1, and a treatment plan including chemotherapy using ports. Ports were placed in 25 patients with high body mass index or pendulous breasts using a conventional technique via the IJV. Before the procedure, written informed consent including advantages and expected complications was obtained from all patients. All ports were placed by one interventional radiologist. If not contraindicated, the left axillary vein was preferred because its course to the superior vena cava (SVC) is more obtuse. Access routes were selected by ultrasound (US) examination of the axillary vein before the procedure. Ports were placed via Table 1 . Underlying Malignancies Malignancies
N (216 Patients)
Breast cancer (left 25, right 31) Stomach cancer
56 29
Colon cancer
28
Lung cancer Rectal cancer
23 12
Lymphoma
11
Esophageal cancer Cholangiocellular carcinoma
7 5
Ovarian cancer
5
Pancreatic cancer Other malignancies
5 35
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the left axillary vein in 172 patients and via the right axillary vein in 44 patients. The most common reason for accessing the right axillary vein was port placement in the contralateral chest for patients with left-sided breast cancer (n ¼ 25) (Table 2). The ports placed included the 6.5-F Celsite Discreet STR or STL type (B. Braun Medical, Boulogne Cedex, France), 6.5-F Celsite ST type (B. Braun Medical), and 8-F Healthport (Baxter Healthcare SA, Zurich, Switzerland) (Table 3). Before disinfecting the skin and sterile draping, the direction of the axillary vein was identified using US guidance, and an incision line was drawn on the skin (Fig 1). The incision line was typically 3 cm lateral to the junction of the axillary vein and clavicle to reduce the risk of pinch-off syndrome and disturbance of shoulder motion. Local anesthesia was injected into the incision line, puncture tract, and port pocket, and a 2-cm vertical incision was made. The axillary vein was punctured under US guidance using a micropuncture needle from a Micronitinol rapid access kit (Access Point Technologies, Rogers, Minnesota). Puncture was initiated at the cephalic end of the incision line for the medial pocket and the midportion for the lateral pocket (Fig 2). A 0.018-inch microwire was advanced, and a microintroducer was inserted. Vein puncture was confirmed by visualization of the microwire in the right atrium on fluoroscopic imaging (Fig 3). Port pockets were created medial or lateral to the incision line by blunt dissection of the subcutaneous tissue. Early on in using this technique, the pocket was created lateral to the incision line for placement of a Celsite ST type or Healthport, and later the pocket was placed medially when the Celsite Discreet port became available. The catheter was introduced through a peel-away sheath.
Table 2 . Reasons for Access via the Right Axillary Vein Reasons
N (44 Patients)
Left-sided breast cancer
25
Lymph node enlargement around left axillary vein
7
Mass in left side of the neck
5
Problems with left axillary vein Dilated vascular structures in
4 2
infraclavicular area Left shoulder pain
1
Table 3 . Types of Ports and Pockets
Medial pocket (n ¼ 123) Lateral pocket (n ¼ 93) Total
Celsite Discreet STR Celsite Discreet STL
Left Axillary Vein
Right Axillary Vein
Total
88 0
0 35
88 35
Celsite ST
42
2
44
Healthport
42 172
7 44
49 216
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After placing the catheter tip in the middle portion of the right atrium and connecting it to the port chamber, the port was implanted in the pocket. A final fluoroscopic image confirmed the position of the catheter tip and port chamber. In all cases, additional plain chest radiographs were obtained to identify immediate complications and to confirm the position of the catheter tip and port chamber (Fig 4a, b). Sutures were removed 7–10 days after the procedure.
Figure 1. Marker for axillary vein direction and the incision line. Two cephalic markers (short arrows) indicate axillary vein direction and two caudal makers (long arrows) indicate the incision line.
Figure 2. Puncture of the axillary vein. For medial pockets, puncture was performed under US guidance at the cephalic end of the incision line. The upper two markers (arrows) indicate the direction of the axillary vein.
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Procedure details were retrospectively reviewed, including technical success rates, location of the micropuncture needle tip on fluoroscopic imaging obtained after puncture, procedure time, fluoroscopy time, extrinsic catheter compression on fluoroscopic imaging, and plain chest radiography performed after the procedure. Complications were identified according to criteria set forth by the Society of Interventional Radiology (SIR) (11). Immediate complications, problems encountered during implantation, and manipulations used to troubleshoot these issues were also retrospectively reviewed. Procedure time was defined as the time from initial imaging after puncture to final imaging after the suture on a picture archiving and communication system. The location of the needle tip was classified according to the following six categories relative to the rib margin: medial, overlapping, or lateral to the first or second rib (Fig 3). If the needle tip was located in the first intercostal space, the location was considered to be near-sided. Medical records and chest computed tomography (CT) scans were retrospectively reviewed to evaluate patient progress, port function, delayed complications, and treatment. The length of follow-up was calculated from port placement to removal or the last follow-up day. Ports were removed in 34 patients. In 123 patients who still had the devices in place, the duration from placement to the cutoff day of March 1, 2013, was calculated. For patients who died (n ¼ 32), were lost to follow-up (n ¼ 17), or were transferred to other hospitals (n ¼ 10) before the cutoff day, the last visit recorded in the medical record was used. Contrast-enhanced chest CT scans were obtained for 192 patients to evaluate
Figure 3. Fluoroscopic image obtained after puncture. The tip of the micropuncture needle (arrow) is located lateral to the lateral margin of the first rib, and the microwire tip is in the right atrium.
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changes in underlying disease and metastasis. Contrast medium (Visipaque 270; GE Healthcare Ireland, Cork, Ireland) was injected into veins of the ipsilateral or contralateral upper extremity or port. On average, 2.5 (range, 1–6) follow-up chest CT scans were performed. The mean duration between port placement and the last day of CT imaging was 133.1 days (range, 0–293 d). On coronal reformatted images, the entry point into the vein was evaluated using the same classification as previously described for the location of the needle tip on fluoroscopic imaging. In addition, catheter-related thrombosis and vein stenosis were evaluated from the brachial vein to the SVC including interruption of flow, filling defects caused by thrombi, and thrombophlebitis. Statistical differences in procedure and fluoroscopy times were analyzed using Student t-tests (SPSS 20.0; SPSS, Inc, Chicago, Illinois).
RESULTS All procedures using the single-incision technique for port placement were successful. Mean fluoroscopy time was 0.65 minutes (range, 0.2–3.5 min), and mean procedure time was 13 minutes, 39 seconds (range, 10
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min, 37 s to 32 min, 22 s) (Table 4). Mean procedure times for medial and lateral pockets were 13 minutes, 16 seconds, and 14 minutes, 10 seconds. Analysis using Student t-tests indicated a statistically significant difference (P ¼ .034). Differences in mean procedure time for right-sided or left-sided access and mean fluoroscopy times according to the method used were not statistically significant. The most common needle tip location was overlapping with the first rib on fluoroscopic imaging, which occurred in 111 cases (51.4%) (Table 5). There were 114 (52.8%) needle tips medial to the lateral margin of the first rib. The entry points into the vein on CT scan were the axillary vein and SCV in 161 and 31 of 192 patients, respectively (Table 5). In 31 cases of SCV puncture, the position of the entry point relative to the clavicle was lateral (n ¼ 22), marginal (n ¼ 6), and overlapping (n ¼ 3). No extrinsic catheter compression or pneumothorax was detected on fluoroscopic or plain chest images obtained after the procedure. Complications were reported in three patients (1.4%), including one major and two minor complications. The major complication was thrombosis of the axillary vein during the follow-up period, and the two minor complications were hematoma formation after accidental punc-
Figure 4. Posteroanterior views on plain chest radiography in the upright position. (a) Celsite Discreet port (STR type) is noted medial to the incision (line) in a male patient. (b) Healthport is noted lateral to the incision (line) in a female patient. The port is located near the shoulder joint and shows caudad migration.
Table 4 . Mean Fluoroscopy and Procedure Times Procedure Time (min:s) Total Access route
Pocket location
n
Statistically significant.
Fluoroscopy Time (min)
13:39 (range, 10:37–32:22)
0.65 (range, 0.2–3.5)
Left (n ¼ 172)
13:48
0.61
Right (n ¼ 44) P value
13:06 .098
0.81 .116
Medial (n ¼ 123)
13:16
0.65
Lateral (n ¼ 93) P value
14:10 .034*
0.64 .832
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Table 5 . Locations of the Needle Tip on Fluoroscopic and CT Imaging 1st Rib
1st Rib
1st Rib
2nd Rib
2nd Rib
2nd Rib
Medial
Overlapping
Lateral
Medial
Overlapping
Lateral
3
28 63
29
2nd rib medial
9
16
12
6
2nd rib overlapping 2nd rib lateral
1
3
11
10
Fluoro/CT 1st rib medial
Total 0
1st rib overlapping 1st rib lateral
No follow-up CT Total
3
31 92
10
3
3
8
111
51
26
24
43 1
26 0
1
216
24
CT ¼ computed tomography; Fluoro ¼ fluoroscopy.
Table 6 . Problems Encountered during the Procedure Problems
N
Advancement of device into unintended vein Catheter tip
33 14
Microwire Spring wire Catheter kinking
11 8 13
Tract bleeding
5
Sheath bending Axillary artery puncture
3 3
Preexisting stenosis of brachiocephalic vein
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ture of the axillary artery. Problems that occurred during the procedure are listed in Table 6. The most common problem was advancement of the wire or catheter into unintended veins, which occurred in 33 patients, although these were easily redirected with minor manipulation under fluoroscopic guidance. This problem occurred in 7 of 44 patients (15.9%) with access via the right axillary vein and 26 of 172 patients (15.1%) with access via the left axillary vein. The catheter tip was wedged into the azygos vein in five cases, and three catheters were advanced into the SVC and right atrium with a “U” shape by pushing from outside of the body. Kinking of the catheter at the junction between the cuff and the catheter occurred in 13 patients, 10 of whom had port pockets that were medial to the incision (8.1%) and 3 of whom had port pockets that were lateral (3.2%) (Fig 5a, b). This kinking was corrected by dissection of the tissue between the puncture tract and port pocket. Bleeding via the puncture tract was observed in five patients, all of whom had lateral pockets. Bleeding resolved completely with placement of a purse-string suture around the port cuff in the subcutaneous tissue. Bending of the peel-away sheath occurred in three patients, all of which were accessed via the right axillary vein. Bending of the peelaway sheath disturbed catheter passage, which was overcome by pulling the sheath while pushing the catheter. The axillary artery was initially punctured in
Figure 5. Catheter kinking at the junction between the cuff and the catheter in cases with a medial (a) and lateral pocket (b).
three patients. The needle was immediately removed, and manual compression was applied to the site. In two patients, axillary vein punctures were remedied by a second puncture under ultrasound guidance. In one patient, the axillary vein had collapsed secondary to hematoma formation, and repuncture was possible only under venography guidance. No cases involved converting
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Figure 6. A 60-year-old man with left axillary vein thrombosis 196 days after port placement. (a) Upper extremity CT venogram obtained before removing the port shows no contrast media filling in the left axillary vein (white arrows) compared with the right axillary vein (black arrows). Infiltration from associated central vein thrombophlebitis is noted in the left axilla. (b) Follow-up CT image obtained after port removal and 3 months of anticoagulation shows restoration of blood flow in the left axillary vein (arrows) and improved thrombophlebitis in the left axilla.
a conventional technique to access via the IJV or contralateral axillary vein. The mean follow-up period was 165.7 days (range, 9– 303 d), and all ports functioned well throughout this time interval. No incision or port pocket infections were reported. The only delayed complication was thrombosis of the axillary vein. One patient complained of left upper extremity edema 196 days after port placement via the left axillary vein. Upper extremity CT venograms obtained the next day showed thrombosis of the left axillary vein with thrombophlebitis of the deep veins in the left upper extremity (Fig 6a). The port was removed, and symptoms improved with anticoagulation therapy over the course of 3 months. Follow-up CT venograms showed resolution of the thrombus (Fig 6b). No case of pinch-off syndrome was identified. Except for the abovedescribed patient, none of the remaining 191 patients showed any evidence of stenosis or thrombosis of the central vein or pulmonary embolism on follow-up CT scans. Ports were removed in 34 patients because of completion of chemotherapy (n ¼ 31), bloodstream infection (n ¼ 2), or axillary vein thrombosis (n ¼ 1). The duration from port placement to removal because of bloodstream infection was 93 days and 256 days.
DISCUSSION Conventional techniques for placing tunneled catheters or ports use two incisions to create a subcutaneous tunnel between the skin exit site or port pocket incision and the venipuncture site. This technique has potential drawbacks, including the use of two separate incisions, cosmetic issues that accompany a neck incision to gain access to the IJV, difficulty advancing tunneling devices, incorrect measurement of catheter length, catheter malfunction, and venous thrombosis (12,13). Creation of subcutaneous tunnels in the deep tissue was not possible because of small amounts of subcutaneous fat, especially
in patients who had undergone gastrectomy for gastric cancer and women with low body mass index. Some patients expressed dissatisfaction with being able to palpate the catheter over the clavicle. Despite use of local anesthesia, tunneling was painful in some patients. Ecchymosis in the overlying skin could occur with gentle advancement of the device through the subcutaneous tissue. To overcome these disadvantages associated with the conventional technique for placing tunneled catheters, a single-incision technique to access the IJV was used via an incision in the infraclavicular area (12–14). Potential advantages of the single-incision technique include cosmetic benefits because of elimination of neck incisions, reduction of discomfort after the procedure, and easier placement in patients with a tracheostomy. However, this technique also has some drawbacks, such as limited subcutaneous tunnel length based on needle length, a potentially inaccessible IJV depending on patient anatomy or available needle length, and difficulty advancing devices with a hairpin-turn shape. The mean procedure time for implanting ports using the previously reported single-incision technique was 25 minutes (range, 18–36 min) from injection of local anesthesia to suture placement. The mean procedure time in the current study was much shorter than that of previous reports, although an exact comparison could not be made. In previous reports, procedure times were much longer when accessing the left IJV. In the current study, the level of difficulty was the same for right-sided and left-sided approaches, and procedure times were similar regardless of the access route. There continues to be controversy regarding which access route and technique are ideal because each carry potential complications. Surgeons have traditionally preferred to access the subclavian vein, cephalic vein, and IJV via cutdown or Seldinger technique under US guidance (3,15–17). The SCV is a suitable anatomic landmark for puncture but can develop symptomatic
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thrombosis and stenosis (16,18). Central venous access via the percutaneous technique has been increasing in popularity more recently. The right IJV is the best route for US-guided access in interventional radiology because of its large diameter, superficial location, straight course to the right atrium, high success rate, and low complication rate (7,9,19,20). Incidence of catheter-related thrombosis is lower when using an IJV versus a SCV approach (8,9,21). Trerotola et al (9) reported 3.2% and 12.6% overall complication rates after central venous access via the IJV and SCV, respectively. The incidence of thrombosis per 100 catheter days was 0.04 and 0.12 in patients with a catheter via the IJV and SCV, respectively. Symptomatic thrombosis is more frequent after access via the SCV, causing acute arm swelling (17). Another risk of access via the SCV includes development of pinch-off syndrome (22). In this study, the axillary vein was punctured instead of the SCV. Axillary vein puncture under US guidance is easier than SCV puncture and reduces the risk of pinchoff syndrome, although it may be more difficult to puncture than IJV. In some cases, the axillary artery was punctured by missing the needle tip during tracing. Micropuncture needle tips were located medial to the lateral margin of the first rib in 114 patients, which is the border between the SCV and the axillary vein. Extrinsic catheter compression was not noted in all patients, and pinch-off syndrome did not develop during the follow-up period in 102 patients. This was likely because the true entry sites were lateral to the lateral margin of the first rib (83.9%) and were located between the clavicle and the first rib in only 3 (1.6%) of 192 cases on follow-up chest CT scan. Only one patient developed symptomatic thrombosis at 196 days after placement, and this incidence was very low (0.5%) compared with previous reports (8,9,21). There was no evidence of thrombosis, stenosis, or pulmonary embolism on follow-up CT scan in 191 patients. However, thrombosis may be underestimated in cases in which the contrast medium was administered via veins in the contralateral upper extremity or port. Factors that influence catheter-related thrombosis are clinician experience, type of catheter, catheter insertion side, catheter tip malposition, indication for catheter placement, and underlying patientrelated risk factors such as a hypercoagulable state (15). Possible reasons for the low incidence of thrombosis in this study are small diameter of the port catheters and use of a less traumatic method for accessing vessels by using a micropuncture needle. Left-sided access was preferred for the single-incision technique because the course to the SVC is more acute on the right side. Another advantage of left-sided access was minimal disturbance of shoulder motion, although the port was implanted near the joint because most people were right-handed, and a medial port pocket incision was preferred to a more lateral one. The mean procedure time was shorter with medial compared with lateral pockets,
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and overall the procedure was simpler. The use of one incision for the port pocket and puncture tract carries a potential risk for bacterial migration into the bloodstream owing to the lack of a subcutaneous tunnel, even though the puncture tract was usually 4 3 cm from incision to entry site (23). Whether the puncture tract formed using the single-incision technique is long enough to provide a barrier against bacterial migration is unknown, but there were no cases of pocket infection in this study. In terms of problems encountered during the procedure, catheter kinking developed mainly during the early period after use of the Celsite Discreet type, and this was corrected by dissection of the tissue between the puncture tract and port pocket. Catheter kinking did not routinely occur after dissection of the tissue. The mechanism by which kinking occurs is likely similar to that seen with the traditional technique, in which there is bending of the catheter between the tunnel and puncture tract. Bending of the peel-away sheath also developed in at least three cases in which the right side was accessed. Early on, the shape of the peel-away sheath was inspected using fluoroscopy if resistance was detected while advancing the catheter through the sheath. After experience with three cases, the peel-away sheath was removed while simultaneously pushing the catheter without fluoroscopic examination. This study has several limitations. First, because this was a retrospective review, some data were unavailable, and port pocket location was not randomized. In addition, patient follow-up and CT imaging were inconsistent. Problems that developed during the follow-up period were likely underestimated because of the number of patients who died, were lost to follow-up, or transferred to other hospitals. Second, patient selection was not consecutive. Patients with high body mass index or pendulous breasts had ports that were placed via the right IJV using the conventional technique. These patients were excluded because migration distances were long, and catheter tips were often located in the SVC despite initial placement in the right atrium. These patients had a high risk of thrombosis because it is anatomically difficult to return the catheter tip to the SVC or right atrium spontaneously in cases of migration into the left brachiocephalic vein. Another reason for exclusion of these patients was difficulty in puncturing the axillary vein because of its deep location. Third, the follow-up period was short, and the longest follow-up time was 300 days. It is possible that the incidence of delayed complications, such as catheter-related venous thrombosis or pinch-off syndrome, may have increased with a longer follow-up period. Fourth, patient satisfaction was not surveyed. However, patients who visited the outpatient interventional radiology department for suture removal after implantation or explantation expressed satisfaction. The most commonly cited reasons were cosmetic advantages over port placement using the conventional technique.
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In conclusion, the single-incision technique for port placement via the axillary vein was a feasible and safe procedure with high technical success and a low risk of complications. This technique may be an alternative approach to traditional port placement. A prospective randomized study comparing this technique with the conventional technique and including long-term followup and surveillance of patient satisfaction is needed.
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